Drug FDA Class I Ongoing Contamination / non-sterility

SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4

Ascent Consumer Products Inc. Published Apr 2, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Ascent Consumer Products Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Hazards

Staphylococcus aureus · primary

Affected products (1)

SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4

unknown

Lot codes: 024122661Al

Code info: Lot# 024122661Al, Exp Date 12/2027

Affected areas

Nationwide

Timeline

Initiated

Jan 28, 2025
Published

Apr 2, 2025

Recall number: D-0300-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.